Levine v. WYETH INC.

• Decision Date: 10 February 2010
• Docket Number: Case No.: 8:09-cv-854-T-33AEP.
• Citation: 684 F. Supp.2d 1338
• Parties: Jason LEVINE, Plaintiff, v. WYETH INC., et al., Defendants.
• Court: U.S. District Court — Middle District of Florida

684 F.Supp.2d 1338

Jason LEVINE, Plaintiff, v. WYETH INC., et al., Defendants.

Case No.: 8:09-cv-854-T-33AEP.

United States District Court, M.D. Florida, Tampa Division.

February 10, 2010.

Daniel J. McGlynn, McGlynn, Glisson, Mouton, Baton Rouge, LA, Jason Richard Fraxedas, Steven R. Maher, The Maher Law Firm, PA, Winter Park, FL, William B. Curtis, Miller, Curtis & Weisbord, LLP, Dallas, TX, for Plaintiff.

Edward W. Gerecke, David J. Walz, Carlton Fields, PA, Tampa, FL, Jeffrey R. Pilkington, Davis, Graham & Stubbs, LLP, Denver, CO, Henniger S. Bullock, Sharon A. Sandell, Mayer Brown LLP, New York, NY, for Wyeth Pharmaceuticals, Inc. and Schwarz Pharma, Inc.

Harold Adam Saul, Kubicki Draper, Tampa, FL, for McKesson Corporation.

C. Howard Hunter, Hill, Ward, Henderson, Tampa, FL, Jon W. Oebker, Nicole Braden Lewis, Richard A. Dean, Tucker, Ellis & West, LLP, Cleveland, OH, for Actavis Elizabeth, LLC and Actavis, Inc.

ORDER

VIRGINIA M. HERNANDEZ COVINGTON, District Judge.

This cause comes before the Court pursuant to a Motion for Summary Judgment (Doc. # 44), filed by Defendants Wyeth, Wyeth Pharmaceuticals Inc., and Schwarz Pharma, Inc. (collectively "Defendants"). On January 13, 2010, the Honorable Anthony E. Porcelli, United States Magistrate Judge, issued a Report and Recommendation (Doc. # 76), recommending that the motion be granted in favor of Defendants.

As of this date, there are no objections to the report and recommendation, and the time for the parties to file such objections has elapsed.

After conducting a careful and complete review of the findings and recommendations, a district judge may accept, reject or modify the magistrate judge's report and recommendation. 28 U.S.C. § 636(b)(1); Williams v. Wainwright, 681 F.2d 732, 732 (11th Cir.1982), cert. denied, 459 U.S. 1112, 103 S.Ct. 744, 74 L.Ed.2d 964 (1983). In the absence of specific objections, there is no requirement that a district judge review factual findings de novo, Garvey v. Vaughn, 993 F.2d 776, 779 n. 9 (11th Cir. 1993), and the court may accept, reject or modify, in whole or in part, the findings and recommendations. 28 U.S.C. § 636(b)(1)(C). The district judge reviews legal conclusions de novo, even in the absence of an objection. See Cooper-Houston v. S. Ry. Co., 37 F.3d 603, 604 (11th Cir.1994); Castro Bobadilla v. Reno, 826 F.Supp. 1428, 1431-32 (S.D.Fla.1993), aff'd, 28 F.3d 116 (11th Cir.1994).

Upon consideration of the Report and Recommendation of the Magistrate Judge and upon this Court's independent examination of the file, it is determined that the Magistrate Judge's Report and Recommendation should be adopted.

Accordingly, it is

ORDERED, ADJUDGED, and DECREED:

(1) Judge Porcelli's Report and Recommendation (Doc. # 76) is ADOPTED, CONFIRMED, and APPROVED in all respects and is made a part of this Order for all purposes, including appellate review.

(2) Defendants' Motion for Summary Judgment (Doc. # 44) is GRATNED.

(3) The Clerk is directed to enter judgment in favor of Defendants Wyeth, Wyeth Pharmaceuticals Inc., and Schwarz Pharma, Inc. and against Plaintiff as to all claims alleged against these Defendants.

REPORT AND RECOMMENDATION

ANTHONY E. PORCELLI, United States Magistrate Judge.

Before the Court is a Motion for Summary Judgment (Dkt. No. 44) filed by Defendants Wyeth, Wyeth Pharmaceuticals Inc., and Schwarz Pharma, Inc. (collectively "Defendants"). For the reasons given below, the Court RECOMMENDS that Summary Judgment be GRANTED in favor of Defendants.¹

I. Factual Background

Plaintiff Jason Levine ("Plaintiff") suffers from tardive dyskinesia, a drug-induced neurological movement disorder. (Dkt. No. 59 pp. 2.) Plaintiff alleges that he developed this condition as a result of ingesting generic metoclopramide, which is used primarily for the treatment of gastrointestinal problems. (Id. pp. 1-2.) Defendants are pharmaceutical corporations that have engaged in, at times relevant to this lawsuit, the manufacture of name brand metoclopramide, sold under the proprietary name Reglan. (Dkt. No. 44 Exs. A-B.)

Plaintiff alleges that Defendants acted as the Reference Listed Drug ("RLD") Holder for Reglan, which was the Reference Listed Drug for generic metoclopramide. Plaintiff concedes he never ingested Reglan or any other metoclopramide made by the Defendants. (Id. Ex. C.) However, Plaintiff argues that despite mounting evidence that long term metoclopramide use carried a risk of tardive dyskinesia far greater than indicated on the label, Defendants failed to take any steps to change the label warnings. Plaintiff cites to multiple studies which suggested that the prevalence and severity of metoclopramide-induced tardive dyskinesia were underestimated, and occurred approximately 100 times more often than previously reported when metoclopramide was used beyond a twelve week period. (See Dkt. No. 59 Exs. A-D.) According to Plaintiff, Defendants either negligently or intentionally distributed false and misleading information regarding the risks of using metoclopramide. (Id. pp. 4.) And although Plaintiff never ingested Reglan or generic metoclopramide made by Defendants, he claims that his physician(s) may have relied on information provided by Defendants (such as information found in labels, promotional materials, package inserts, etc.) when they prescribed him generic metoclopramide. (Id. pp. 6.)

Plaintiff's causes of action are set forth generally against each of the named defendants in this action. Accordingly the Court considers each cause of action as they pertain to the instant Motion and Defendants. With respect to Count I alleging negligence, Plaintiff asserts that Defendants owed a duty to the general public to exercise reasonable care in the marketing of metoclopramide and breached that duty because they failed to warn that, as designed, metoclopramide was capable of causing serious personal injuries such as those suffered by Plaintiff. (Dkt. No. 1 ¶ 98.) Additionally, Plaintiff alleges, inter alia, that Defendants represented to physicians that Reglan was safe and effective for use, that Defendants failed to provide adequate training or information to medical care providers for appropriate use of Reglan, and that Defendants failed to warn the public that Reglan should not be prescribed for more than twelve weeks. (Id. ¶¶ 99(a)-(j).)

As to Count II, Plaintiff alleges Defendants are strictly liable under a products liability theory for placing into the stream of commerce a defective and unreasonably dangerous product. (Id. ¶ 103.) Although Plaintiff concedes that he did not ingest Defendants' drug, Plaintiff argues in his Opposition that the package insert/labeling information formed part of an overall product. (Dkt. No. 59 pp. 17-18.) Plaintiff asserts that Defendants are the equivalent of a component part manufacturer because they provided the information in the insert/label which was allegedly defective. (Id.) Additionally, Plaintiff alleges under Count III that Defendants breached their express and implied warranties of merchantability because the metoclopramide was unfit for its intended purposes. (See Dkt. No. 1 ¶¶ 106-08.)

Under Count IV, Plaintiff alleges that Defendants materially misrepresented or fraudulently concealed adverse information regarding the safety and effectiveness of metoclopramide. Specifically, Plaintiff alleges Defendants concealed from Plaintiff and the public that metoclopramide use significantly increased the probability of neuromuscular side effects, that metoclopramide should not be used for more than twelve weeks, and that it was not fully and adequately tested. (Id. ¶ 114.)

Finally, Plaintiff alleges in Count V that Defendants committed negligence per se because the product label and package insert for metoclopramide was misbranded within the meaning of 21 U.S.C. §§ 352(a) and (f), since it was false and misleading and failed to give adequate warnings and directions for use by physicians who prescribe it. (Id. ¶ 117.)

Defendants argue in their Motion that a plaintiff cannot hold a manufacturer liable under any theory of product liability if the plaintiff never used the manufacturer's product. Defendants point to a plethora of case law that have found that brand drug manufactures cannot be held liable for injuries allegedly caused by ingestion of their competitors' generic drugs.² Finally, Defendants contend that holding brand manufacturers responsible for injuries caused by generic manufacturers would have devastating consequences on the pharmaceutical industry.

II. Standard for Summary Judgment

Summary judgment is appropriate where "there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(c)(2). A dispute about a material fact is genuine if the evidence is such that a reasonable jury could return a verdict for the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). In reviewing the motion, the Court must view the evidence and all factual inferences in a light most favorable to the non-moving party, and all reasonable doubts about the facts are resolved in favor of the non-movant. Dadeland Depot, Inc. v. St. Paul Fire and Marine Ins. Co., 483 F.3d 1265, 1268 (11th Cir.2007) (citations omitted).

When a party fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial, there can be "no genuine issue as to any material fact," since a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). "The moving party is `entitled to a judgment as a matter of law' because the nonmoving party has failed to make a sufficient showing on an essential element of her...